As we approach the end of celebrating Women’s History Month, we’re taking a closer look at the biopharmaceutical progress made and challenges to be addressed for women’s health.
Innovations in women’s health have prolonged and extended lives. In breast cancer, the second leading cause of cancer death in women, death rates have fallen 42% from 1989 through 2019. In cervical cancer, which is almost always caused by the human papillomavirus (HPV), widespread use of the HPV vaccine has driven down prevalence of HPV infection in teenage girls by 86% and 71% in young adult females since the vaccine has been in use in the United States. And today, we now have a treatment for endometriosis, a painful condition caused when tissue similar to the lining of the uterus grows outside of the uterus.
This progress is part of a biopharmaceutical ecosystem that continues to bring new innovative treatment solutions for women’s health. In a new report, PhRMA explores the research and development pipeline of medicines in clinical trials or under review by the U.S. Food and Drug Administration (FDA) for diseases which solely or disproportionately impact women.
While considerable progress has been made, women experience unique health challenges throughout their lifetime. Women are more likely to be diagnosed with certain diseases than men – such as autoimmune diseases, depression, osteoporosis, Alzheimer’s disease and more. Nearly 40% of women will be diagnosed with a chronic disease, compared to 30% of men. Furthermore, due to gender bias in health care, women can also be misdiagnosed, which can ultimately delay proper care and treatment. Minority patients can face additional challenges due to racial disparities in health care.
Additionally, while the COVID-19 pandemic has had a negative impact on the mental health of all Americans, women are reported to bear a disproportionate share. Gender roles, family caregiving responsibilities for children and elderly family members, combined with workforce participation contribute to the unique mental health challenges faced by women.
To address these challenges, America’s biopharmaceutical research companies are developing 625 medicines targeting diseases that disproportionately or solely affect women. Among the medicines include:
- 200 medicines for cancers primarily affecting women including 119 for breast cancer, 66 for ovarian cancer, 4 for uterine cancer and 22 for cervical cancer. It’s estimated that, all together, these cancers will kill more than 76,000 women in 2022.
- 133 for neurologic disorders including Alzheimer’s, migraine and multiple sclerosis.
- 87 for autoimmune diseases, which are twice as prevalent among women including lupus, myasthenia gravis, scleroderma and Sjogren’s syndrome.
- 45 for mental health disorders, which are also twice as prevalent among women, including anxiety disorders, depression, postpartum depression and eating disorders.
- 43 for respiratory diseases that disproportionately affect women, including asthma and chronic obstructive pulmonary disease.
- 37 for arthritis and musculoskeletal disorders, including fibromyalgia, osteoporosis and rheumatoid arthritis.
- 34 for eye diseases, including dry eye disease.
- 33 for obstetric/gynecologic health issues, including endometriosis, menopausal symptoms, polycystic ovarian syndrome, pregnancy complications and uterine fibroids.
- 23 for infectious diseases affecting women, including candidiasis, chlamydia, genital herpes and urinary tract infections.
- 14 for other diseases that disproportionately affect women, including chronic fatigue syndrome, interstitial cystitis, irritable bowel syndrome and urinary incontinence.
Critical to bringing new medicines to patients are clinical trials. The biopharmaceutical industry is committed to taking steps to enhance the diversity of clinical trial participants, including with regard to sex/gender. Enhancing diversity in clinical trial populations can lead to studies better reflecting the patient populations most likely to use the product once it is approved. This can include understanding how pregnant or lactating women can safely participate in the clinical trial process where appropriate.
Policymakers have taken a number of recent steps to further enhance the understanding of how medicines may affect pregnant and lactating women. For example, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), established under the 21st Century Cures Act in December 2016, offered a list of recommendations and an implementation plan to the U.S. Health and Human Services Secretary to promote the inclusion and integration of pregnant women and lactating women into clinical research. Further, the FDA issued guidance for industry on the inclusion of pregnant women in clinical trials providing recommendations about how and when to include pregnant women in drug development trials. Finally, the PDUFA VII goals letter, negotiated by industry and FDA, contains commitments to further enhance understanding of medicines used with pregnant and lactating women. This includes new Sentinel demonstration projects for assessing pregnancy outcomes in women and the development of a framework addressing the use of pregnancy registries and electronic health care data sources including Sentinel, with a goal of ensuring the most efficient means of obtaining highest quality safety data available.
As we look to the future, America’s biopharmaceutical research companies are making significant strides in developing new treatments and cures for diseases that disproportionately impact women. I’m looking forward to highlighting these efforts at the upcoming sixth annual Women’s Conference of Florida. In addition to this new report, I’ll also be speaking to PhRMA’s broader work to advance and advocate for equitable access to innovative medicines; and how the biopharmaceutical industry is addressing important issues such as disparities in access to medicines, increasing diverse talent in the industry, and clinical trial diversity.
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